The present invention relates to a system and method for opening/dilating and closing a tissue access site and, more particularly, to a system which can be used to open/dilate and close large vascular access sites, such as those utilized in femoral vascular access.
More than five million percutaneous interventions are performed annually in the United States, involving femoral artery catheterization for diagnostic or therapeutic purposes.
Most procedures are performed through small sheath access sites (5-8F) and thus closure of such access sites can be effected using manual or mechanical compression for 15-30 minutes, typically combined with an extended bed-rest of three to six hours.
However, manual compression can cause patient discomfort, and is time- and resource-intensive, and as such, a need for quicker, more patient compatible closure has led to the introduction of closure devices in the early 1990s. Since then, vascular closure systems have been simplified to provide wider patient access to a range of vascular procedures. Now available from many sources, these devices shorten procedure times, allow patients to ambulate earlier, minimize bleeding and possibly reduce costs associated with hospital care.
At present there are dozens of devices on the market or at various stages of development, such devices employ sutures, patches, glue, coagulants and/or staples or a source of energy to effectively seal access sites post procedure.
Although these devices were specifically designed for closure of small access sites (<10F), there have been attempts since the late 90s to utilize suture closure devices (specifically the Sutura and Perclose devices) in large bore access sites >18F, illustrating at least a limited need for ‘automated’ closure of large access sites. Large bore access site closure is typically effected via manual suturing of an exposed artery and thus requires presence of a specialist while being time consuming as well as more invasive.
The studies performed to date illustrate that closure of access sites less than 18F in size via such devices is effective and highly successful, whereas closure of larger bore access sites (e.g. 22F) is less effective.
Although at present the number of procedures effected through large bore access sites is small, current trends anticipate that the number of such procedures will rise in the future and although a concomitant reduction in sheath sizes might also take place, such reduction will still place average sheath size at over 18F.
While reducing the present invention to practice, the present inventors have devised an access site system which provides the physician with control over access site generation and closure.